CN110339229B - 一种降黏清血组合物及其应用 - Google Patents
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Abstract
本发明公开了一种降黏清血组合物,包括以下重量份数的原料:青钱柳3‑20份、多穗柯3‑20份、黄杞1‑10份、三七茎叶3‑25份、牛磺酸1‑5份,所述降黏清血组合物可以加入药学上可接受的辅料制成各种剂型,或者加入食品辅料制成液体食品或者固体食品,实现降低血液黏度、清血通脉的效用。
Description
技术领域
本发明涉及食品、药物组合物技术领域,更具体的说是涉及一种降黏清血组合物及其应用。
背景技术
血液是人体中最重要的体液,是人体吸收、运输、排泄各种物质的重要载体,正常的血液流变性是维持脏器和组织正常血液灌注、正常代谢功能的重要条件,表现为相对稳定的血液相对密度、酸碱度、渗透压及黏度等理化参数。其中血液黏度是人体生命状态的一项重要综合性指标,与疾病的病因机制探讨、治疗、预后判断、疗效观察等方面密切相关,血液黏度是血液最基本的流变学参数,且在保持血管稳态中发挥着重要作用,主要由血细胞、血浆大分子物质含量等血液成份决定,并受温度、酸碱度及渗透压等理化条件的影响,在生理状态下,机体能通过多种调节机制保持血液黏度相对稳定;血液黏度异常与高血压、心肌梗塞、脑血栓、高脂血症和糖尿病等疾病的发生、发展密切相关,一些慢性疾病如糖尿病、高脂血症等由于病期长,血液中各种大分子物质如糖类、蛋白质、酶类、酯类含量和浓度的升高,改变血管内外渗透压的平衡,红细胞压积、血浆蛋白浓度、纤维蛋白原、高糖高脂环境的异常均会引起血液黏度异常,一些如高血压、冠心病、动脉硬化等慢性疾病也会造成血管、血液稳态的改变,在病理条件下,血管内皮细胞功能障碍等也会引起血液黏度调节机制异常。
《内经》指出“人之所有者,血与气耳”、“人之血气精神者,所以奉生而周于性命也。”明代《景岳全书》记载“人有阴阳,即为血气。人生所赖,惟斯而已。”传统医学认为血以营养、滋润为主,血液黏稠、流速迟缓等则表现为“瘀”,血脉不通,传统中医药常以活血化瘀治疗。
因此,如何提供一种降低血液黏度、清血通脉的组合物是本领域技术人员亟需解决的问题。
发明内容
有鉴于此,一方面,本发明依据传统中医药理论和现代药理研究成果,以青钱柳、多穗柯、黄杞、三七茎叶和牛磺酸为原料制成组合物,具有降低血液黏度、清血通脉的效用;
另一方面,本发明还提供了所述组合物在制备降黏清血的食品或药品上的应用。
为了达到上述目的,本发明采用如下技术方案:
一种降黏清血组合物,包括以下重量份数的原料:青钱柳3-20份、多穗柯3-20份、黄杞1-10份、三七茎叶3-25份、牛磺酸1-5份。
优选的,在上述降黏清血组合物中,包括以下重量份数的原料:青钱柳8份、多穗柯8份、黄杞4份、三七茎叶16份、牛磺酸1份。
具体的,青钱柳为胡桃科青钱柳Cyclocarya paliurus(Batal.)ljinsk的嫩叶或枝干。
多穗柯为壳斗科石柯属多穗柯Lithocarpus polystachyrus Rehd的嫩叶或枝干。
黄杞为胡桃科黄杞Engelhardtia roxburghiana wall的嫩叶或枝干。
三七茎叶为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的茎和叶。
牛磺酸为食品级或药用级的β-氨基乙磺酸。
本发明还公开了一种上述组合物在制备降黏清血的药物制剂或者食品中的应用。
优选的,在上述一种降黏清血组合物的应用中,所述药物制剂包括所述降黏清血组合物和药学上可接受的辅料。
优选的,在上述一种降黏清血组合物的应用中,所述药物制剂的剂型为溶液剂、颗粒剂、胶囊剂或者片剂。
优选的,在上述一种降黏清血组合物的应用中,所述食品包括所述降黏清血组合物和食品上可接受的辅料。
优选的,在上述一种降黏清血组合物的应用中,所述食品为液体食品或者固体食品。
优选的,在上述一种降黏清血组合物的应用中,所述药学上可接受的辅料或食品上可接受的辅料为甜味剂、酸味剂、防腐剂、着色剂、崩解剂、填充剂、润滑剂、粘合剂中的一种或者多种。
优选的,在上述一种降黏清血组合物的应用中,所述甜味剂是选自白砂糖、果糖、葡萄糖、蜂蜜、饴糖、麦芽糖醇、山梨醇、甜蜜素、淀粉糖浆、果葡糖浆、蛋白糖等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述酸味剂是选自醋、山梨酸、柠檬酸、乳酸等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述防腐剂是选自苯甲酸、苯甲酸钠、柠檬酸钠、山梨酸、山梨酸钠、醋、尼泊金甲酯、尼泊金乙酯等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述着色剂选自食用色素苋菜红、胭脂红、柠檬黄、栀子黄、靛蓝、赤鲜红、亮蓝、栀子蓝、焦糖色等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述崩解剂选自淀粉、微晶纤维素、羧甲基纤维素钠、碳酸氢钠、枸橼酸等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述填充剂选自预胶化淀粉、糊精、糖粉、微晶纤维素等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述润滑剂选自硬脂酸、硬脂酸钙、硬脂酸镁、滑石粉、聚乙二醇等中的一种或多种。
优选的,在上述一种降黏清血组合物的应用中,所述粘合剂选自蔗糖、明胶、预胶化淀粉等中的一种或多种。
青钱柳,是胡桃科青钱柳属植物的树叶部分,《中国中药资源志要》记载其具有清热解毒、止痛功能,《全国中草药名鉴》记载有杀虫止痒、消炎止痛祛风之功效,广泛分布于广西、贵州、江西等地,民间泡茶用于动脉硬化、糖尿病、高血压、脑中风等心脑血管疾病防治。现代研究发现,青钱柳含多糖类、黄酮类、萜类、甾体类、有机酸等化学成分,具有降糖、降压、降脂、增强免疫、抗癌的多种药理作用。
多穗柯,是广西民间用于保健的甜茶之一,主要含根皮苷、三叶苷,具有清热化痰、生津止渴、解暑的功能,民间用于肺热咳嗽、高血压的预防与治疗。现代研究发现,多穗柯主要含根皮苷、三叶苷、3-羟其根皮苷、根皮素等化学成分,具有降糖、抗过敏、抗氧化、改善记忆能力的药理作用。
黄杞,是《广西壮族自治区壮药质量标准》2011年第二卷第178页黄杞项的壮药材,在广西民间作为甜茶饮用,具有清热解毒、生津解渴、解暑利湿的功效,可用于脾胃湿滞、胸腹胀闷、感冒发烧的治疗。现代研究发现,黄杞含黄酮、二芳基庚烷、萘醌、紫罗兰酮、倍半萜、三萜、酚类化合物等化学成分,具有抗过敏、抗癌、降血糖、降血脂、增强机体免疫力、抗炎的药理作用。
三七茎叶,是《中国药典》2015年版第一部11页三七项下植物的地上部分,在广西、云南民间用于煲汤或泡茶使用,味辛,性温,归肝、胃经,含三七叶苷、多糖类、黄酮类等化学成分,三七茎叶的主要成份及含量均与三七药材有较大差异,其除具有活血化瘀、镇痛消炎、消肿生肌、降血脂、抗疲劳、滋补强壮的作用外,还具有三七药材缺乏的镇静安神、促进消化等功效。
牛磺酸,不参与蛋白质合成,但与胱氨酸、半胱氨酸的代谢密切相关,人体主要依靠从食物中摄取来满足机体需要,具有促进婴幼儿脑组织和智力发育、提高神经传丑时和视觉机能、防止心血管病、改善内分泌等多种生理功能,在循环系统抑制血小板凝集、保持人体正常血压和防止动脉硬化的作用,可以作为药物或食品营养添加剂,应用于食品或药品,发挥生理或药效作用。
经由上述的技术方案可知,与现有技术相比,本发明提供的组合物有如下优点:
(1)本发明组合物的组方原则以清热化痰为治则,通过清热化痰利湿之主药材,减少血液中大分子物质含量,使血液水含量相对增加,降低血液黏度,辅以活血化瘀之药材,进一步降低血液黏度、缓解血瘀病症,获得降黏清血的效果,本发明组方原则有着突出的特点,与传统中医药理论的“活血化瘀”“益气活血”治则有着明显的区别。
(2)本发明组合物依据组方原则,青钱柳清热解毒、多穗柯清热化痰、黄杞清热解毒解渴利湿,统合三药清热、化痰、利湿之功,共为君药,三七茎叶活血化瘀、促进消化为臣药,化瘀通脉以助君药化痰利湿之效,牛磺酸为使药在循环系统发挥作用,五药合用,清、化、通相辅相成,共凑降黏清血之效。
(3)本发明组合物配伍合理,不仅降低血液中血糖、总胆固醇、甘油三酯异常增高,还降低异常的血液黏度。
(4)本发明组合物组方合理,在减少血液的血糖、总胆固醇和甘油三酯异常增高方面,或降低血黏度方面,组合物的组合效果均明显优于青钱柳、多穗柯、黄杞、三七茎叶和牛磺酸的单独应用效果。
(5)本发明采用的原料为民间常用药食两用原料或食品营养添加剂,安全有效,适用于药品或食品制备。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1:
青钱柳200g、多穗柯200g、黄杞100g、三七茎叶400g、牛磺酸25g。
制备方法:青钱柳、多穗柯、黄杞分别水洗,晾干,杀青备用;三七茎叶洗净,干燥,打成细粉,加入牛磺酸,混匀备用;青钱柳、多穗柯、黄杞、三七茎叶与牛磺酸混合细粉按照2:2:1:4的比例称取分装成500包袋泡茶,即得。
实施例2:
青钱柳300g、多穗柯400g、黄杞100g、三七茎叶400g、牛磺酸50g。
制备方法:三七茎叶洗净,干燥,打成细粉,备用;青钱柳、多穗柯、黄杞加水煮2小时,过滤,滤渣再加水煮1小时,过滤,合并滤液,滤液浓缩至适量,加入预胶化淀粉、三七茎叶细粉、牛磺酸,混匀制成颗粒,即可。
实施例3:
青钱柳30g、多穗柯200g、黄杞100g、三七茎叶30g、牛磺酸50g。
制备方法:将青钱柳、多穗柯、黄杞、三七茎叶加水煮2小时,过滤,滤渣再加水煮1小时,过滤,合并滤液,滤液中加入牛磺酸,搅拌溶解,加入柠檬酸、果糖、蜂蜜等辅料,搅拌均匀,过滤,灌装,灭菌处理,即得。
实施例4:
青钱柳80g、多穗柯80g、黄杞40g、三七茎叶160g、牛磺酸10g。
制法方法:如实施例3的制备方法。
实施例5:
青钱柳200g、多穗柯30g、黄杞10g、三七茎叶250g、牛磺酸30g。
制法方法:如实施例3的制备方法。
试验例1:
患有2型糖尿病的患者16人、高血脂患者8人,试验前采用微量血浆黏度计测定血浆黏度,糖尿病人员采用瑞特血糖仪测定血糖,高血脂人员采用生化仪测定总胆固醇(TC)及甘油三酯(TG)含量,记录清晨空腹血糖值、血脂值及血黏度,然后泡服实施例1的袋泡茶,每天三包,连续1个月,1个月后再检查上述三项指标,血糖值平均下降12%,总胆固醇含量下降11.6%,甘油三脂含量下降16.7%,血黏度下降至正常,结果参见表1:
表1
注:与试验前进行T检验,*表示P<0.05;**表示P<0.01。
试验例2:
45%高糖高脂饲料制备:55%基础饲料,添加猪油18%、蔗糖20%、蛋黄2%和胆固醇5%,混匀,制粒,保存备用。
取KM小鼠90只,雌雄各半,小鼠质量均为20±2g,饲养于SPF级实验室。将90只小鼠随机分为正常对照组、模型对照组、第一、第二、第三、第四对照组及第一、第二、第三试验组,每组10只,雌雄各半;正常对照组以基础饲料饲养,其余各组以45%高糖高脂饲料饲养;正常对照组及模型对照组灌胃给予蒸馏水,其余各组灌胃分别给予各试验样品,连续1个月,给药方案参见表2:
表2
实验结束后,取小鼠血,测血糖(瑞特血糖仪)、总胆固醇(迈瑞氧化酶法TC测定试剂盒)、甘油三酯(迈瑞氧化酶法TG测定试剂盒)及血浆黏度(赛科希德血流变测试分析仪)。
试验结果如下:高糖高脂饲料喂养1个月,模型对照组、第一、第二、第三、第四对照组及三组试验组小鼠血液的血糖、总胆固醇、甘油三酯与正常对照组比较有显著性差异(P<0.01),模型对照组、第一、第二、第三、第四对照组及三组试验组小鼠的血黏度与正常对照组比较也有显著性差异(P<0.01),说明造模成功,试验结果参见表3:
表3
注:与正常对照组相比,**表示P<0.01;与模型对照组相比,▲表示P<0.05,▲▲表示P<0.01。
表3的试验结果显示,实施例3~5组合物具有如下优点:
(1)第一、第二、第三、第四对照组及三组试验组小鼠的血糖、总胆固醇、甘油三酯、血黏度均低于模型对照组,其中三组试验组均有统计学意义(P<0.05或P<0.01),说明实施例3~5提供的组合物不仅具有降低血液中异常增加的血糖、总胆固醇、甘油三酯的功能,并具有降低血液黏度的效果。
(2)第一、第二、第三、第四对照组与模型对照组比较,对血糖、总胆固醇、甘油三酯没有明显改善,而三个试验组均有显著性改善,说明实施例3~5组合物在原料剂量方面比各原料单独应用的用量更少,而在降血糖、降总胆固醇、降甘油三酯作用方面比各原料单独应用的效果更优越。
(3)第一、第二、第三对照组与模型对照组比较,对血液黏度没有明显改善,而三个试验组均有显著性改善,三个试验组与第四对照组(三七茎叶牛磺酸组合物)比较亦有明显提高,说明以小剂量原料组合的实施例3~5组合物在降低血液黏度方面比各原料单独应用的效果更优越。
(4)在第一、第二、第三试验组中,第二试验组的降血糖、降总胆固醇、降甘油三酯、降血黏度作用均优于第一、第三试验组,说明第二试验组(实施例4的组合物)具有最佳的降黏清血效果。
上述试验结果表明,青钱柳、多穗柯、黄杞、三七茎叶、牛磺酸以实施例3~5组合后的降黏清血效果比各原料单独应用效果更优越,特别是实施例4提供的组合物(青钱柳、多穗柯、黄杞、三七茎叶和牛磺酸的重量份比为8:8:4:16:1)改善效果最为显著。
本说明书中各个实施例采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似部分互相参见即可。
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (5)
1.一种降黏清血组合物,其特征在于,由以下重量份数的原料制成:青钱柳3-20份、多穗柯3-20份、黄杞1-10份、三七茎叶3-25份、牛磺酸1-5份。
2.根据权利要求1所述的降黏清血组合物,其特征在于,由以下重量份数的原料制成:青钱柳8份、多穗柯8份、黄杞4份、三七茎叶16份、牛磺酸1份。
3.一种权利要求1-2任一项所述的组合物在制备降黏清血的药物制剂中的应用。
4.根据权利要求3所述的降黏清血组合物的应用,其特征在于,所述药物制剂包括所述降黏清血组合物和药学上可接受的辅料。
5.根据权利要求4所述的降黏清血组合物的应用,其特征在于,所述药物制剂的剂型为溶液剂、颗粒剂、胶囊剂或者片剂。
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